Clinical Trial
Open access until Jan. 16, 2025

Disease: Chronic Hepatitis B, HBV, (NCT06671093)

Disease info:

Chronic hepatitis B is an inflamed state of the liver that is caused by infection with hepatitis B virus (HBV). HBV can cause both an acute (short-term) or chronic (long-term) infection. The virus spreads through contact with blood, semen and other body fluids from a HBV-infected person. The inflammation causes damage to the liver and in rare cases it can cause liver failure. Long term, it can also cause cirrhosis (scarring of the liver) and liver cancer. The virus integrates its DNA into the host genome, and thus, may remain latent for several years until reactivation. 

The symptoms of acute hepatitis B include yellowing of skin and eyes, dark yellow urine, diarrhoea, fever, fatigue, nausea, joint- and abdominal pain. In chronic hepatitis B, the symptoms may not show until years after the infection has taken place, after which treatment is needed. 

Treatment of chronic hepatitis B includes oral antiviral agents such as tenofovir or entecavir. These medications selectively inhibit the viral reverse transcriptase, a crucial enzyme that the virus needs to replicate itself. 

Frequency:
WHO estimates that a total of 296 million people worldwide are living with chronic hepatitis B, with 1.5 million new infections each year. The frequencies vary a lot from area to area, but is most common in Eastern Asia and Africa.
Official title:
Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection
Who:

Contact

Phone: 855 755 8863

Email: clinical.operations@tunetx.com

Partners:
Locations:

Auckland, New Zealand

New Zealand Clinical Research, Auckland, New Zealand, 1010

Study start:
Nov. 29, 2024
Enrollment:
36 participants
Gene editing method:
Epigenetic editing
Type of edit:
Gene silencing
Gene:
Hepatitis B viral genome
Delivery method:
Lipid nanoparticles - In-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This study consists of an open-label, single-ascending dose phase, which will identify the dose for evaluation in a cohort expansion. The expansion phase will be open-label to further characterize the activity of Tune-401 on PD parameters and obtain additional safety data.

Last updated: Jan. 13, 2025
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